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Completed

NCT Number: NCT00015171

Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

Completed

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Key information

Conditions

Heroin Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New York MDRU

New York, 10010, United States

About this study

The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age

Exclusion criteria

Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

Treatment and study plan

buprenorphine/naloxone

Drug

Primary outcomes

  1. Craving

  2. Drug use

  3. Retention

  4. Opioid withdrawal

  5. Subjective rating

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • New York MDRU

Registry information

Official study title

CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence

Important dates

Study start
1996
Primary completion
1997
Study completion
1997
First posted
Apr 18, 2001
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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